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A Randomized, Double-Blind, Controlled Study of the Safety and Performance of the NIRx™ Paclitaxel-Coated Conformer Coronary Stent

NCT00299026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2017-03-03

No results posted yet for this study

Summary

The clinical investigation is an international, prospective, double-blind, randomized safety and efficacy study. The purpose of this study is to evaluate the safety and performance of the NIRx(TM) Paclitaxel-Coated Stent (1.0µg/mm2 of paclitaxel incorporated into slow- and moderate-release formulation of a triblock copolymer carrier system)in patients who present for stenting of de novo lesions of a native coronary artery.

Conditions

Interventions

DEVICE

NIRx(TM) Paclitaxel-Coated Conformer Coronary Stent System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Antonio Colombo, MD · Ospedale San Raffaele del Monte Tabor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2003-05-31
Completion
2007-02-28

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299026 on ClinicalTrials.gov